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Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers

NCT00569777 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2015-03-06

Study results available
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Summary

The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers

Conditions

  • Allergic Conjunctivitis

Interventions

DEVICE

K-Lens (generic name not established) and Ketotifen

combination drug-device product: contact lens (device) and anti-allergy drug

DEVICE

Placebo Lens

contact lens without drug

Sponsors & Collaborators

  • Vistakon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Brian Pall, OD, MS, FAAO · Johnson & Johnson Vision Care, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-02-29
Completion
2008-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00569777 on ClinicalTrials.gov